復星醫藥(02196.HK):氟尿嘧啶注射液用於治療結腸與直腸腺癌、乳腺癌、胃腺癌以及胰腺癌藥品註冊申請獲國家藥監局審評受理
格隆匯6月28日丨復星醫藥(02196.HK)公吿,近期,上海復星醫藥(集團)股份有限公司(以下簡稱“本公司”)控股子公司吉斯美(武漢)製藥有限公司(以下簡稱“吉斯美”)研發的氟尿嘧啶注射液(以下簡稱“該新藥”)用於治療結腸與直腸腺癌、乳腺癌、胃腺癌以及胰腺癌的藥品註冊申請獲國家藥品監督管理局審評受理。
該新藥為吉斯美自主研發的化學藥品,擬主要用於治療結腸與直腸腺癌、乳腺癌、胃腺癌以及胰腺癌。
截至公吿日,於中國境內(不包括港澳台地區,下同)已上市的氟尿嘧啶注射液同類產品主要包括上海旭東海普藥業有限公司、天津金耀藥業有限公司的氟尿嘧啶注射液和山西普德藥業有限公司的注射用氟尿嘧啶等。根據IQVIACHPA最新數據(由IQVIA提供,IQVIA是全球領先的醫藥健康產業專業信息和戰略諮詢服務提供商;IQVIACHPA數據代表中國境內100張牀位以上的醫院藥品銷售市場,不同的藥品因其各自銷售渠道佈局的不同,實際銷售情況可能與IQVIACHPA數據存在不同程度的差異),2021年度,氟尿嘧啶注射液同類產品於中國境內銷售額約為人民幣11.50億元。
截至2022年5月,本集團(即本公司及控股子公司/單位,下同)現階段針對該新藥累計研發投入約為人民幣287萬元(未經審計)。
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